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Completed

NCT Number: NCT01702974

Immune Reconstitution in HIV Disease (IREHIV)

The aim with this study is to provide immunotherapy with vitamin D and phenylbutyrate to treatment-naive HIV infected patients to induce important antimicrobial defence mechanisms and decreased inflammation.

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Inflammation Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Black Lion Hospital (BLH), Addis Ababa University, Faculty of Medicine

Addis Ababa, Lideta sub city, Ethiopia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients >18 years not subjected to HAART.

HIV-1 infected patients with CD4 T cells counts >200 cells/ml.

Detectable plasma viral loads >1000 copies/ml.

Exclusion criteria

Patients on HAART or other antimicrobial drugs (including bactrim).

Antimicrobial drug treatment in the past month.

Patients with medical contra-indication for biopsy such as bleeding tendencies.

Hypercalcaemia (serum calcium > 3,0 mmol/L) identified at baseline.

Pregnant and breast feeding women.

Any known liver or kidney function abnormality, malignancy or patients treated with cardiac glycosides.

Treatment and study plan

vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)

Drug

Dose of interventions: 5,000 IU of vitamin D (cholecalciferol tablets) once daily and 500 mg PBA (sodium phenylbutyrate tablets) twice daily for 16 weeks.

Placebo tablets

Drug

Placebo tablets for vitamin D once daily and placebo tablets for PBA (phenylbutyrate) twice daily for 16 weeks.

Primary outcomes

  1. HIV viral load

    Time frame: 0 (baseline) compared to 16 weeks.

    Plasma HIV viral load will be used to monitor efficacy of vitamin D and phenylbutyrate treatment among treatment-naïve HIV patients at the time of diagnosis (time point 0) and at 4, 8, 16 and 24 weeks after initiation of antimicrobial treatment with vitamin D and phenylbutyrate. The primary endpoint will be assessed at 16 weeks compared to baseline (time point 0).

Secondary outcomes

  1. Clinical secondary endpoints

    Time frame: 0, 4, 8, 16, 24 weeks.

    Overall clinical symptoms.

    Body mass index (BMI).

    Mid upper arm circumference (MUAC).

  2. Laboratory secondary endpoints

    Time frame: 0, 4, 8, 16, 24 weeks.

    HIV viral load (0, 4, 8, 24 weeks).

    Peripheral CD4/CD8 T cell counts.

    Plasma levels of vitamin D, LL-37, sCD14, LPS, 16S RNA and cytokine/chemokine profiles.

    Calprotectin in feces.

    Inflammation and microbial translocation in colon punch biopsies (0 and 16 weeks).

    Functional studies of immune cells (PBMCs).

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Addis Ababa University
  • Armauer Hansen Research Institute, Ethiopia

Registry information

Official study title

Immune Reconstitution in HIV Disease Using Antimicrobial Treatment With Vitamin D and Phenylbutyrate

Acronym: IREHIV

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 10, 2012
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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